MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C311 STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04826876001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot numbers and expiration dates were not provided.The field service engineer performed acceptable precision testing prior to and after cleaning of the ise flow path and checking adjustments.He verified that the rinse levels were correct and everything was operating correctly.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results from the cobas 4000 c311 stand alone system.The initial sodium result was 155 mmol/l, and the repeat results were 140 mmol/l and 140 mmol/l.The initial potassium result was 5.65 mmol/l, and the repeat results were 4.79 mmol/l and 4.84 mmol/l.The initial chloride result was 114 mmol/l, and the repeat results were 103 mmol/l and 102.6 mmol/l.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The sodium electrode lot number was epe with an expiration date of 20-jul-2026.The potassium electrode lot number was evb with an expiration date of 15-aug-2026.The chloride electrode lot number was evp with an expiration date of 13-jun-2026.Based on the provided information, the investigation was unable to determine a specific root cause.The analyzer alarm trace contained multiple abnormal probe sucking errors.These are indicators of possible poor sample quality.Correct pre-analytic sample handling is within the customer's responsibility.There was no evidence to reasonably suggest there was a device malfunction.The issue appeared to be resolved after the service actions.

• Brand Name: COBAS 4000 C311 STAND ALONE SYSTEM
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24152867
• Report Number: 1823260-2026-00248
• Device Sequence Number: 10031280
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male